Mandatory EUDAMED Use Implemented from 28th May, 2026

European database on medical devices (EUDAMED) is the European Commission’s digital platform for medical device and IVD regulation. It is aimed to enhance transparency, traceability, and regulatory coordination across the European Union. As of 28^th May, 2026, EUDAMED has officially become mandatory under EU MDR and IVDR. This is a critical compliance milestone for all medical device and IVD companies operating in the EU. The system has a phased roll-out across six modules. From 28^th May, 2026, four modules, namely actor registration, UDI/device registration, notified bodies and certificates, and market surveillance, are compulsory. Hence, manufacturers, importers, distributors, and notified bodies must now use EUDAMED’s modules for registration, surveillance, and certification. The shift marks the end of voluntary use and the beginning of full enforcement. Thus, making mandatory EUDAMED use essential for EU market access.

What is European database on medical devices (EUDAMED)?

European database on medical devices (EUDAMED) is the European Commission’s centralized IT system for medical device and IVD. It has been designed to enhance transparency, traceability, and coordination across EU Member States. EUDAMED serves as the digital backbone for regulatory oversight across the EU medical device ecosystem. It integrates six interconnected modules. Each module is designed to streamline regulatory processes, improve public access to device information, and strengthen post-market oversight. By centralizing data on medical devices, economic operators, clinical studies, and safety reports, EUDAMED supports harmonized market surveillance. Additionally, it fosters greater trust in the safety and performance of medical devices and IVD across the EU. EUDAMED is designed to fulfil the following core regulatory functions under the EU MDR:

• Ensure transparency of medical device information and regulatory activities
• Enable traceability of medical devices and economic operators via UDI and SRN
• Facilitate coordination among Competent Authorities, Notified Bodies, and the European Commission
• Strengthen post-market surveillance and vigilance reporting
• Streamline clinical investigation management and performance study tracking

6 modules of EUDAMED

As mandatory EUDAMED use is being implemented, it is important to understand the six modules of EUDAMED. Each module serves a distinct regulatory function to support EU MDR compliance. Together, they create a unified digital infrastructure for device regulatory oversight, transparency, and safety.

1. Actor registration module: The actor registration module registers all economic operators, i.e., manufacturers, authorized representatives, importers, and clinical investigation sponsors. It assigns a Single Registration Number (SRN) to each actor, which is required for accessing other modules.
2. UDI/device registration module: The UDI/device registration module captures Unique Device Identification (UDI) and device-specific data. Basic UDI-DI, device risk class, intended purpose, and regulatory status are recorded.
3. Notified bodies and certificates module: This module records notified body details and conformity assessment certificates. CE certificates issued under MDR/IVD and scope of designation for each notified body are covered in this module.
4. Clinical investigations and performance studies module: This module focuses on applications, approvals, and results of clinical investigations (MDR) and performance studies (IVDR). It covers submission portal for sponsors as well as status tracking and result publication. It promotes harmonized evaluation and public access to clinical evidence.
5. Vigilance and post-market surveillance module: This module focusses on centralizing reporting of serious incidents, Field Safety Corrective Actions (FSCA), and Periodic Safety Update Reports (PSURs). It covers incident trend analysis and coordination of corrective actions across member states. Thus, this module focusses on strengthening post-market safety and rapid response mechanisms.
6. Market surveillance module: The market surveillance module enables competent authorities to share surveillance activities, findings, and enforcement actions. This module covers inspection reports and non-compliance alerts.

Mandatory EUDAMED use implementation: Why EUDAMED matters now?

• Regulatory enforcement: From 28 May 2026 onwards, four modules, actor registration, UDI/device registration, notified bodies and certificates, and market surveillance, are now compulsory. Thus, EUDAMED is no longer optional. All regulatory activities must be conducted through EUDAMED.
• Transparency and traceability: Citizens, healthcare providers, and regulators can view device information. Devices will be tracked across the EU via a Unique Device Identifier (UDI) system. Faster detection and response to adverse events.
• Industry benefits: Single Registration Number (SRN) issued by national authorities, thereby eliminating multiple country-specific submissions. Centralized registration for devices and system/procedure packs. Streamlined compliance across all EU member states.
• Compliance deadlines: All economic operators (manufacturers, authorized representatives, importers, sponsors) must register by 28 May 2026. New devices must be registered before placement on the market. Existing devices must be registered by 28 November 2026 (12 months grace). Notified bodies have up to 18 months to upload existing MDR/IVDR certificates.
• Strategic impact: Non-compliance means devices cannot legally be sold in the EU. Companies must align QMS, technical documentation, and vigilance processes with EUDAMED. Supply chain partners must also comply to avoid regulatory gaps.

The Four mandatory modules

We have detailed the four EUDAMED modules that became mandatory on 28 May 2026 under EU MDR and IVDR

1. Actor registration

• Who it applies to: Manufacturers, authorized representatives, importers, and sponsors.
• Key requirement: Each actor must register in EUDAMED and obtain a Single Registration Number (SRN) issued by their national competent authority.
• Why it matters: The SRN is now the official identifier for all regulatory activities in the EU, replacing fragmented national registrations.

2. UDI/device registration

• Scope: All medical devices and IVDs placed on the EU market.
• Key requirement: Devices must be registered with their Unique Device Identifier (UDI) in EUDAMED.
• Why it matters: Ensures traceability, public transparency, and harmonized device data across all EU member states.

3. Notified bodies and certificates

• Who it applies to: Notified Bodies issuing MDR/IVDR certificates.
• Key requirement: Certificates must be uploaded into EUDAMED.
• Why it matters: Creates a centralized record of conformity assessments, making oversight more efficient and reducing fraud or duplication.

4. Market surveillance

• Who it applies to: National Competent Authorities.
• Key requirement: Authorities must record surveillance activities, inspections, and enforcement actions in EUDAMED.
• Why it matters: Strengthens regulatory oversight, ensures consistent enforcement across the EU, and improves public trust in device safety.

What should medical device manufacturers and importers do now?

We have presented a structured action plan for manufacturers and importers now that mandatory EUDAMED use (from 28 May 2026) has been implemented under EU MDR/IVDR.

For manufacturers

• Actor registration: Register in EUDAMED and obtain your Single Registration Number (SRN). Additionally, ensure all subsidiaries and authorized representatives are registered.
• UDI/device registration: Map your entire device portfolio. Register new devices before market placement.
• Certificates upload: Coordinate with your notified body to ensure MDR/IVDR certificates are uploaded.
• QMS integration: Update SOPs to include EUDAMED workflows. Train regulatory teams on module-specific requirements. Moreover, align vigilance and post-market surveillance processes with EUDAMED.

For importers

• Actor registration: Obtain SRNs for all importing entities. Additionally, verify that overseas manufacturers are registered and compliant.
• Device traceability: Ensure imported devices carry valid UDIs registered in EUDAMED. Additionally, maintain documentation for customs and regulatory inspections.
• Supplier governance: Audit foreign suppliers for MDR/IVDR compliance. Moreover, establish contracts requiring timely certificate uploads and device registration.
• Market surveillance readiness: Be prepared for EU authorities to monitor imports via EUDAMED. Furthermore, maintain records of distribution and adverse event reporting.

From May 28, 2026 mandatory EUDAMED use implementation marks a decisive turning point for EU MDR and IVDR compliance. This marks the end of the transition period and beginning of full enforcement. By centralizing actor registration, device traceability, certificate oversight, and market surveillance, it eliminates fragmented national systems and creates a unified regulatory backbone. This shift enhances transparency, strengthens post‑market vigilance, and improves public trust in medical devices and IVDs across the EU. Notably, non‑compliance will directly translate into market access restrictions. For any assistance with EU MDR/IVDR or CE mark certification, feel free to email at [email protected] or call/Whatsapp on 9996859227.